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A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570749
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Baricitinib Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 824 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : February 2, 2021
Estimated Study Completion Date : June 24, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Baricitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Drug: Placebo
Administered orally.
Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Drug: Placebo
Administered orally.
Placebo Comparator: Placebo
Participants administered orally.
 Drug: Placebo
Administered orally.
Experimental: Open-Label Addenda Baricitinib High Dose
Baricitinib will be administered orally during the open-label addenda.
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]
    Percentage of Participants Achieving SALT ≤ 20


Secondary Outcome Measures :
  1. Percentage of Participants Achieving 50% Improvement of SALT (SALT50) [ Time Frame: Week 12 ]
    Percentage of participants achieving SALT50

  2. Percent Change from Baseline in SALT Score [ Time Frame: Baseline, Week 36 ]
    Percent change from baseline in SALT score

  3. Time for Participants to Achieve SALT ≤ 20 [ Time Frame: Baseline through Week 36 ]
    Time for Participants to Achieve SALT ≤ 20

  4. Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for EyeBrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from Baseline (Among Participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving ClinRO measure for EB hair loss 0 or 1 with ≥2-point improvement from Baseline (among participants with ClinRO measure for EB hair loss ≥2 at baseline)

  5. Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 with ≥2-point improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving ClinRO measure for EL hair loss 0 or 1 with ≥2-point improvement from Baseline (among participants with ClinRO measure for EL hair loss ≥2 at baseline)

  6. Percentage of Participants Achieving PRO Measure for EB 0 or 1 with ≥2-point improvement from Baseline (Among Participants with Patient Reported Outcome (PRO) Measure for EB ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving PRO measure for EB 0 or 1 with ≥2-point improvement from Baseline (among participants with PRO measure for EB ≥2 at baseline)

  7. Percentage of Participants Achieving PRO Measure for EL 0 or 1 with ≥2-point improvement from Baseline (Among Participants with PRO Measure EL ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving PRO measure for EL 0 or 1 with ≥2-point improvement from Baseline (among participants with PRO measure EL ≥2 at baseline)

  8. Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score [ Time Frame: Week 36 ]
    Mean Change From Baseline in HADS Anxiety Score

  9. Mean Change From Baseline in HADS Depression Score [ Time Frame: Week 36 ]
    Mean Change From Baseline in HADS Depression Score


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
  • Must self-identify as either Black or African American in race in the open label addenda.

  • Have severe or very severe AA, as determined by all of the following:

    • Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT Alopecia Areata Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline.
    • No spontaneous improvement over the past 6 months.
    • Current episode of severe or very severe AA of less than 8 years.
  • Male or nonpregnant, nonbreastfeeding female participants.

Exclusion Criteria:

  • Primarily "diffuse" type of AA.
  • Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
  • Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570749


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03570749    
Other Study ID Numbers: 16582
I4V-MC-JAHO ( Other Identifier: Eli Lilly and Company )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical